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ADVANCE MPI 1: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00208299
First received: September 13, 2005
Last updated: November 24, 2009
Last verified: November 2009
History of Changes
  Purpose

Adenoscan® (adenosine) is an approved pharmacological stress agent indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. The investigational drug, regadenoson (CVT-3146) is a selective A2A adenosine receptor agonist, the receptor responsible for coronary vasodilation, and is being studied for potential use as a pharmacologic stress agent in myocardial perfusion imaging (MPI) studies. This study will compare the safety and efficacy of regadenoson to that of Adenoscan in detecting reversible myocardial perfusion defects.


Condition Intervention Phase
Coronary Artery Disease
 Drug: Regadenoson
Drug: Adenosine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Phase III, Randomized, Double-Blind Study of Intravenous CVT-3146 Versus Adenoscan® in Patients Undergoing Stress Myocardial Perfusion Imaging

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Non-inferiority of regadenoson to Adenoscan for use in single photon emission computed tomography (SPECT) myocardial perfusion imaging in assessing reversible perfusion defects [ Time Frame: After radiopharmaceutical administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability comparison of regadenoson to Adenoscan [ Time Frame: Up to two weeks ] [ Designated as safety issue: Yes ]
  • Additional comparisons of images obtained with regadenoson to those obtained with Adenoscan [ Time Frame: After radiopharmaceutical administration ] [ Designated as safety issue: No ]

Enrollment: 1231
Study Start Date: October 2003
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Regadenoson
 Drug: Regadenoson
0.4 mg, bolus intravenous injection
Other Names:
  • Lexiscan
  • CVT-3146
Active Comparator: 2
Adenoscan
 Drug: Adenosine
0.14 mg/kg/min for 6 minutes, intravenous infusion
Other Name: Adenoscan

Detailed Description:

ADVANCE MPI 1 is a multi-national, double-blind, randomized, active-controlled, parallel group clinical trial to evaluate the safety and efficacy of regadenoson in SPECT MPI compared to that of the approved pharmacological stress agent, Adenoscan. Patients referred for a clinically indicated pharmacological stress MPI study will be eligible for enrollment. The trial is designed:

  • to compare the pharmacological stress SPECT images obtained with regadenoson to those obtained with Adenoscan, and
  • to compare the safety and tolerability of the two stress agents.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Referred for a clinically indicated pharmacological stress SPECT myocardial perfusion imaging study

Exclusion Criteria:

  • Any condition precluding the safe administration of Adenoscan for a SPECT myocardial perfusion imaging study
  • Pregnant or breast-feeding, or (if pre-menopausal), not practicing acceptable method of birth control
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208299

Locations
United States, California
Multiple study locations (see Central Contact); CV Therapeutics, Inc.
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Gilead Sciences
Astellas Pharma US, Inc.
  More Information

Additional Information:
Adenoscan®  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Philip Sager, Vice President, Clinical Research, Gilead Sciences
ClinicalTrials.gov Identifier: NCT00208299     History of Changes
Other Study ID Numbers: CVT 5131
Study First Received: September 13, 2005
Last Updated: November 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Lexiscan
Regadenoson
Adenoscan®
 Adenosine
SPECT Myocardial Perfusion Imaging
Reversible Perfusion Defect

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Adenosine
Regadenoson
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents
Adenosine A2 Receptor Antagonists
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013